Q'Apel Medical Inc קיבלה אישור CE תחת MDR עבור Walrus, הקטטר מונחה הבלון של החברה


Q‘Apel Medical Inc קיבלה אישור CE תחת MDR עבור Walrus, הקטטר מונחה הבלון של החברה


Q‘Apel Medical Inc קיבלה תו אישור CE תחת MDR עבור Walrus, הקטטר מונחה הבלון (BGC) המוביל בשוק האמריקאי המשמש בטיפול בחולים הסובלים משבץ איסכמי חריף. ה-Walrus BGC נמצא בשימוש בידי רופאים העוסקים בניתוחים פולשניים מאז 2019 וטיפל בהצלחה ביותר מ-20,000 חולים בארצות הברית.


Q‘Apel Medical Inc. Granted CE Mark Under MDR for Their Walrus Balloon Guide Catheter

FREMONT, CA / March 28, 2023, ACCESSWIRE:

Q‘Apel Medical Inc. was granted the CE Mark under MDR for Walrus, their U.S. market-leading Balloon Guide Catheter (BGC) utilized in treating patients suffering an acute ischemic stroke. The Walrus BGC has been utilized by Neuro Interventional physicians since 2019 and has successfully treated over 20,000 patients in the United States.

The Walrus BGC is a unique development in the field of Mechanical Thrombectomy procedures. It provides physicians with not only the known benefits of BGC use clinically, but unique to Walrus, superior ease of use in preparation in these urgent procedures. Importantly, Walrus enables the physicians to navigate the catheter into a more distal location easily and safely compared to other systems, which is associated with improved patient outcomes from stroke.

"The anticipation of Walrus in our international markets has been enormous, and we look forward to the same performance and loyalty around Walrus we have been fortunate to experience in the United States," said King Nelson, Q‘Apel Medical‘s CEO.

"We are thrilled to be entering the EU and other international markets with Walrus and providing more physicians in more countries the unparalleled performance of our flagship catheter. This CE Mark certification represents a significant growth milestone for Q‘Apel Medical providing access to new markets," commented Jodie Fam, Chief Marketing Officer & GM International.

About Q‘Apel Medical

Q‘Apel Medical designs highly innovative technologies for neurovascular interventions and unmet clinical needs. Q‘Apel‘s portfolio comprises three products, the Walrus Balloon Catheter System, the Wahoo Hybrid Access System and Armadillo Radial Access System. Before Walrus came along, balloon-based variable stiffness catheters brought all manner of technological constraints. Not anymore. By blending flow control, trackability, support, and access into one revolutionary solution, Walrus offers truly unmatched functionality. The Wahoo Hybrid Access System and Armadillo Radial Access System are dual-mode catheters and part of the SelectFlex™ Family of Neurovascular Catheters. These devices feature two distinct operational modes, allowing physicians to easily switch modes at any point during a clinical case and reducing the need for multiple catheters in challenging procedures.

Media Contact: Jodie Fam
415 244 9885

+44 7500702108


Contact Information

Jodie Fam
Chief Marketing Officer & GM International

SOURCE: Q‘Apel Medical Inc.


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